Anorectal Dysfunction in Patients Suffering From Spina Bifida : From Clinic to Neuro-epithelial Function (ANOSPIN)

Spina Bifida Clinical Trial

— ANOSPIN  

Official title:

Anorectal Dysfunction in Patients Suffering From Spina Bifida : From Clinic to Neuro-epithelial Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02440984
• Other study ID #: 2015-A00082-47
• Secondary ID: 35RC15_8926
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2015
• Est. completion date: December 15, 2019

Study information

• Verified date: August 2018
• Source: Rennes University Hospital
• Contact: Charlène Brochard, Md
• Email: charlene.brochard[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess and explain (at least apart) anorectal disorders of patients with Spina Bifida by an automatic neuropathy responsive of enteric nervous system and epithelial barrier dysfunctions. The investigators' aim hypothetics is that autonomic neuropathy of patients with Spina Bifida induce enteric nervous sytem and epithelial barrier dysfunctions which explain anorectal disorders of these patients. Thexpect to show a decreased of 5% of enteric neurons per ganglia.

Description:

Spina Bifida is rare disease related to a failure of the closure of neural tube during the embryonic period. This malformation results in a variety of clinical disorders (neurologic, urologic, orthopedic, anorectal), depending on the level of the spinal cord lesion. Anorectal functional disorders remain underestimated and unknown from a pathophysiological point of view with subsequent uncodified therapeutic strategy.

Patients with Spina Bifida always present autonomic neuropathy that contributes partially to the anorectal disorders. These disorders may be related to a closed relationship between autonomic and enteric nervous system. Both nervous systems play a key role in anorectal disorders during others neurological disaeses have a common and simultaneous development from neural crest and induce colonic epithelial changes related to the closed connection between epithelial barrier and enteric nervous system. All of this remains hypothetic because no data regarding the impairment of enteric nervous system and epithelial barrier are available and no study are ongoing on this topic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patient aged between 18 and 65 years old

• patient who consulted to the national Spina Bifida Center for multidisciplinary assessment or for a proctology/urologic clinic

• need of colonic biopsies during endoscopy

• free, written and informed consent

Exclusion Criteria:

• pregnancy or breastfeeding

• protected adults (judicial protection, guardianship and truesteeship) and persons deprived of liberty

• patient unable to giving their consent

• anticoagulants therapy or coagulation disorders

Related Conditions & MeSH terms

• Spina Bifida
• Spinal Dysraphism

Intervention

Procedure:
• Colonic biopsies during endoscopy
eligible patients will have physical examination, colonic biopsies during endoscopy and anal manometry with barostat. these investigations are part of the usual healthcare. Colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of enteric neurons per ganglia	all data will be collected in the Spina Bifida database for further analyses. Colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system	data collected at the day of endoscopy
Secondary	anorectal symptoms		data collected at the day of endoscopy
Secondary	Rectal compliance	Rectal compliance is defined by a volume variation during ascending pressure (phasic distension). It will be performed with a bag connected to electronic barostat.	data collected at the day of endoscopy
Secondary	Likert scale	Sensation intensity will be measured at each pressure step, by using 6-point Likert scale ranging from 0 (no sensation) to 6 (intolerable pain)	data collected at the day of endoscopy
Secondary	macroscopic and microscopic colonic inflammation		data collected at the day of endoscopy
Secondary	intestinal permeability marker	Intestinal permeability will be measured using Ussing chamber.	data collected at the day of endoscopy
Secondary	number of glia cells per ganglia		data collected at the day of endoscopy